Fabius GS Premium Anesthesia Machine; Cat. no. 8607000 Product Usage: Inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Fabius series machines are equipped with a compact breathing system; providing fresh gas decoupling, PEEP, and pressure limitation. The following ventilation options are available: Volume Controlled Ventilation Pressure Controlled Ventilation Pressure Support (Optional) SIMV/PS (Optional) Manual Ventilation Spontaneous Breathing Fabius series anesthesia machines are equipped with an electrically driven and electronically controlled ventilator and monitors for airway pressure (P), volume (V), and inspiratory oxygen concentration (FiO2). As per IEC 60601-2-13 (Anesthetic Workstations and their Modules-Particular Requirements), additional monitoring of the concentrations of CO2 and anesthetic agent is required when the machine is in use. IEC 60601-2-13:2003 requires that a manual ventilation bag must be available for emergency use. Fresh gas enrichment is provided by the Dr¿ger Vapor anesthetic vaporizer. Fabius MRI can also be used in MRI scanner rooms with magnets 1.5 tesla and 3 tesla at a fringe field strength of 40 mtesla or less
Class I - DangerousWhat Should You Do?
- Check if you have this product: ASKM-0102 ASKM-0220 ASKM-0103 ASKM-0221 ASKM-0124 ASKM-0222 ASKM-0125 ASKM-0223 ASKM-0129 ASKM-0224 ASKM-0132 ASKM-0229 ASKM-0133 ASKN-0061 ASKM-0134 ASKN-0090 ASKM-0135 ASLA-0035 ASKM-0136 ASLA-0046 ASKM-0137 ASLA-0047 ASKM-0138 ASLA-0048 ASKM-0139 ASLA-0049 ASKM-0189 ASLA-0050 ASKM-0190 ASLA-0053 ASKM-0191 ASLA-0070 ASKM-0192 ASLA-0071 ASKM-0193 ASLA-0072 ASKM-0194 ASLA-0073 ASKM-0195 ASLA-0074 ASKM-0198 ASLA-0075 ASKM-0199 ASLA-0129 ASKM-0200 ASLA-0131 ASKM-0201 ASLA-0133 ASKM-0202 ASLA-0140 ASKM-0204 ASLA-0141 ASKM-0205 ASLA-0159 ASKM-0207 ASLA-0199 ASKM-0208 ASLA-0200 ASKM-0215 ASLA-0201 ASKM-0219 ASLA-0218
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Draeger Medical, Inc.
- Reason for Recall:
- The Draeger anesthesia device may be able to dose 100% N2O. In the event of a fault, the S-ORC module would not prevent setting an N2O flow that would result in a hypoxic mixture from being dosed to the patient. Potential adverse outcomes include death of the patient.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Fabius GS Premium Anesthesia Machine; Cat. no. 8607000 Product Usage: Inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Fabius series machines are equipped with a compact breathing system; providing fresh gas decoupling, PEEP, and pressure limitation. The following ventilation options are available: Volume Controlled Ventilation Pressure Controlled Ventilation Pressure Support (Optional) SIMV/PS (Optional) Manual Ventilation Spontaneous Breathing Fabius series anesthesia machines are equipped with an electrically driven and electronically controlled ventilator and monitors for airway pressure (P), volume (V), and inspiratory oxygen concentration (FiO2). As per IEC 60601-2-13 (Anesthetic Workstations and their Modules-Particular Requirements), additional monitoring of the concentrations of CO2 and anesthetic agent is required when the machine is in use. IEC 60601-2-13:2003 requires that a manual ventilation bag must be available for emergency use. Fresh gas enrichment is provided by the Dr¿ger Vapor anesthetic vaporizer. Fabius MRI can also be used in MRI scanner rooms with magnets 1.5 tesla and 3 tesla at a fringe field strength of 40 mtesla or less
Product Codes/Lot Numbers:
ASKM-0102 ASKM-0220 ASKM-0103 ASKM-0221 ASKM-0124 ASKM-0222 ASKM-0125 ASKM-0223 ASKM-0129 ASKM-0224 ASKM-0132 ASKM-0229 ASKM-0133 ASKN-0061 ASKM-0134 ASKN-0090 ASKM-0135 ASLA-0035 ASKM-0136 ASLA-0046 ASKM-0137 ASLA-0047 ASKM-0138 ASLA-0048 ASKM-0139 ASLA-0049 ASKM-0189 ASLA-0050 ASKM-0190 ASLA-0053 ASKM-0191 ASLA-0070 ASKM-0192 ASLA-0071 ASKM-0193 ASLA-0072 ASKM-0194 ASLA-0073 ASKM-0195 ASLA-0074 ASKM-0198 ASLA-0075 ASKM-0199 ASLA-0129 ASKM-0200 ASLA-0131 ASKM-0201 ASLA-0133 ASKM-0202 ASLA-0140 ASKM-0204 ASLA-0141 ASKM-0205 ASLA-0159 ASKM-0207 ASLA-0199 ASKM-0208 ASLA-0200 ASKM-0215 ASLA-0201 ASKM-0219 ASLA-0218
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2250-2018
Related Recalls
The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Component: Not applicable
Draeger Medical
The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.